45 unchanged sentences
Maximum Total Shares of Common Stock to be Sold Under the Plan (2)
−Removed: Steve Krognes
−Removed: 12/1/2023 3/1/2025 282,500
+Added: Carole Ho, M.D.
+Added: Chief Medical Officer 12/11/2024 3/12/2026 373,374
+Added: Alexander Schuth, M.D.
+Added: Chief Operating and Financial Officer 12/30/2024 3/31/2026 176,026
__________________________________________________
2 unchanged sentences
No other officers or directors, as defined in Rule 16a-1(f), adopted and/or terminated of a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as defined in Regulation S-K Item 408, during the fourth quarter ended December 31, 2024.
+Added: Entry into a Material Definitive Agreement
+Added: On February 24, 2025, Denali and Sanofi executed a side letter terminating the CNS program portion of their Collaboration Agreement dated October 29, 2018.
+Added: Under the Collaboration Agreement, certain CNS and peripheral RIPK1 small molecule inhibitors (the "CNS Products" and "Peripheral Products," respectively) were to be developed and commercialized.
+Added: The side letter terminated provisions of the Collaboration Agreement relating to CNS Products , including Sanofi’s obligations to make milestones or other payments to Denali on future development and commercialization of CNS Products, and delineated the parties' ongoing rights and obligations.
+Added: Sanofi will continue to develop eclitasertib (SAR443122/DNL758), a Peripheral Product discovered by us, and licensed to Sanofi under the Collaboration Agreement.
+Added: Sanofi is currently conducting a Phase 2 clinical trial for eclitasertib in patients with UC , and we remain eligible to receive milestones and tiered royalties on net sales for Peripheral Products sold worldwide.
+Added: Entry into a Material Definitive Agreement
+Added: In February 2025, after mutual agreement to discontinue preclinical activities on ATV:TREM2, Takeda delivered notice of its election to terminate the ATV:TREM2 program on February 26, 2025, as per the terms of the Takeda Collaboration Agreement dated January 3, 2018.
+Added: Under the Takeda Collaboration Agreement, Denali had granted Takeda options with respect to the ATV:BACE1/Tau, ATV:TREM2 and PTV:PGRN programs in exchange for an upfront payment of $40.0 million and an additional $110.0 million under a February 2018 share purchase agreement.
+Added: The Takeda Collaboration Agreement became effective in February 2018, following satisfaction of certain requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
+Added: The ATV:Tau program was substituted for the ATV:BACE1/Tau program via amendment of the Takeda Collaboration Agreement in February 2019, and in March 2022, the parties mutually agreed to terminate activity on the ATV:Tau program.
+Added: Takeda exercised its option for the PTV:PGRN program in November 2021 and the parties have continuing obligations with r espect to this program under the Takeda Collaboration Agreement.
+Added: We are eligible to receive payments under the Takeda Collaboration Agreement for PTV:PGRN upon the achievement of certain clinical and sales-based milestones or upon achievement of certain regulatory milestones relating to regulatory approval in the United States, certain European countries, and Japan.
+Added: Further, we and Takeda share equally the development and commercialization costs, and, if applicable, will share the profits, for the PTV:PGRN program.
+Added: Takeda exercised its option for the ATV:TREM2 program in December 2021.
+Added: On February 26, 2025, after mutual agreement to discontinue preclinical activities on ATV:TREM2, we received notice of Takeda's election to terminate the ATV:TREM2 program effective sixty days following the date of the notice from Takeda, or earlier if mutually agreed by the parties.
+Added: Takeda's notice terminated provisions of the Collaboration Agreement relating to the ATV:TREM2 program, including those related to future milestones, cost or profit sharing.
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
24 unchanged sentences
3.2 Amended and Restated Bylaws of the Registrant.
−Removed: 8-K 001-38311 3.2 12/12/2017
+Added: 001-38311 3.1 11/18/2024
4.1 Specimen Common Stock Certificate of the Registrant.
S-1/A 333-221522 4.2 11/27/2017
−Removed: 4.2 Form of Indenture.
−Removed: S-3ASR 333-263107 4.3 2/28/2022
−Removed: 4.3 Form of Pre-Funded Warrant
+Added: Form of Pre-Funded Warrant (A mended)
001-38311 4.1 5/7/2024
87 unchanged sentences
10-Q 001-38311 10.1 8/4/2021
−Removed: 10.30 Equity Distribution Agreement, dated February 28, 2022 between the Registrant and Goldman Sachs & Co.
−Removed: LLC, SVB Securities LLC and Cantor Fitzgerald & Co.
−Removed: S-3ASR 333-263107 1.2 2/28/2022
Amendment to Definitive LRRK2 Agreement and Waiver of and Amendment to Right of First Negotiation, Option, and License Agreement.
10-Q 001-38311 10.1 11/7/2023
−Removed: 10.32 S ecurities Purchase Agreement , dated February 27, 2024 , by and among the Company and the Purchasers named therein
+Added: 10.31 Securities Purchase Agreement, dated February 27, 2024, by and among the Company and the Purchasers named therein
001-38311 10.1 2/27/2024
2 unchanged sentences
10.33 Compensation Recovery Policy (“Clawback Policy”)
−Removed: — — — Filed herewith
+Added: 10-K 001-38311 10.34 2/28/2024
+Added: Denali - Biogen Side Letter
+Added: 10-Q 001-38311 10.10 8/1/2024
19.1 Denali Insider Trading Policy and Guidelines with Respect to Certain Transactions in Securities as amended through March 31, 2023 .
−Removed: — — — Filed herewith
+Added: 10-K 001-38311 10.35 2/28/2024
21.1 Subsidiaries of the Registrant.
2 unchanged sentences
— — — Filed herewith
+Added: 24.1 Powers of Attorney (incorporated by reference to the signature page hereto)
31.1 Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act.
13 unchanged sentences
Ü Portions of the exhibit have been omitted pursuant to an order granted by the Securities and Exchange Commission for confidential treatment.
−Removed: # Portions of this exhibit have been omitted pursuant to a request for confidential treatment and this exhibit has been filed separately with the SEC.
+Added: # Certain confidential information contained in this exhibit has been omitted because it is both (i) not material and (ii) is the type that the Registrant treats as private or confidential.
+ Indicates management contract or compensatory plan.
36 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.